Officer

5-12 years

Not Disclosed

Halol

10 Dec. 25, 2024

Job Description

Job Type: Full Time Education: M. Pharm Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Responsibilities:

Document Authorization:
- Authorized to sign as a Doer & as a Checker in the following documents:
  - Risk Assessment: Review and ensure all risks are assessed and mitigated.
  - Process Validation Protocol: Ensure compliance with validation procedures.
  - Incident and Investigation Reports: Oversee accurate documentation of incidents and investigations.
  - CAPA (Corrective and Preventive Actions) Plans and Closure: Approve and oversee implementation and closure of CAPA plans.
  - Protocols and Reports: Ensure protocols are followed and reports are accurate.
  - Internal Quality Audit Compliance and Closure: Oversee the audit process and ensure compliance.
  - Change Control: Authorize and manage changes in production procedures.
  - Standard Operating Procedures (SOPs): Ensure SOPs are up to date and followed.
  - Planned Modifications: Approve and review modifications in production processes.
  - Any other documents required for the execution of activities.
Investigation and Root Cause Analysis:
- Participate in investigations and root cause analysis for issues like OOS (Out of Specification), OOT (Out of Trend), incidents, complaints, audit observations, and deviations.
- Propose relevant CAPAs to the Quality Management System (QMS) team to address these issues.
Regulatory and Internal Audit Readiness:
- Ensure continuous readiness for regulatory agency inspections and internal audits.
- Implement corrective actions based on observations made by regulatory agencies and internal audit teams.
Complaint and Deviation Handling:
- Ensure that market complaints, failures, and deviations are investigated thoroughly.
- Implement corrective and preventive actions within the set timelines.
Documentation and Manufacturing Oversight:
- Oversee production documentation activities in the Parenteral Production Department, ensuring all records are maintained and compliant with standards.
Department Maintenance and Equipment:
- Ensure that the department, premises, and equipment are properly maintained in accordance with regulatory standards.
Guidance and Standardization:
- Provide guidance to officers to standardize production activities for improved efficiency and quality.
Additional Responsibilities:
- Any other responsibilities assigned by the Department Head after ensuring the relevant training status.

This role involves a significant level of responsibility in managing compliance, process optimization, and documentation related to manufacturing and production in a Parenteral Production Department, with a focus on meeting regulatory requirements and quality standards.

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